RAC Practice Exam – Complete Guide for Regulatory Affairs Certification

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Question: 1 / 195

What is the primary role of Institutional Review Boards (IRBs)?

To approve marketing strategies for drugs

To review biomedical research for human subject protection

The primary role of Institutional Review Boards (IRBs) is to review biomedical research for the protection of human subjects involved in that research. IRBs are committees established to ensure that the rights, welfare, and privacy of individuals participating in research studies are safeguarded. They assess research proposals to identify any potential risks to human subjects and ensure that appropriate ethical standards and regulatory guidelines are being followed.

In this context, the review process involves evaluating the research protocols, informed consent documents, and the overall design of the study to make sure that participants are not exposed to unnecessary risks and that their participation is voluntary and informed. This is crucial in maintaining public trust in the research process, ensuring ethical considerations are addressed, and setting standards for the treatment of human subjects.

Other choices focus on activities that, while important in their respective domains, do not align with the specific mission of IRBs in the realm of human subject protection.

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To supervise clinical trial training programs

To evaluate financial implications of drug approvals

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